DIAPER RASH CREAM- zinc oxide cream

Diaper Rash Cream by

Drug Labeling and Warnings

Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by Hello Bello. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide - 40%

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product,

do not get into eyes

Stop use and ask a doctor

if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• Change wet and soiled diapers promptly.
• Cleanse the diaper area and allow to dry.
• Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

• Do not use if quality seal is broken
• Do not store above 40C (104F)

Inactive Ingredients

Helianthus Annus (Sunflower) Seed Oil*, Ricinus Communis (Castor) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Polyhydroxystearic Acid, Helianthus Anuus (Sunflower) Seed Wax*, Cocos Nucifera (Coconut) Oil*, Theobroma Cacao (Cocoa) Seed Butter*, Colophyllum Tacamahaca Seed Oil*, Tocopherol*, Zea Mays (Corn) Starch*

*Organic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIAPER RASH CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
STARCH, CORN (UNII: O8232NY3SJ)
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA BUTTER (UNII: 512OYT1CRR)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-300-08	1 in 1 CARTON	10/13/2023
1	NDC: 73418-300-04	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/13/2023

Labeler - Hello Bello (081135707)